CLORAZEPATE DIPOTASSIUM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLORAZEPATE DIPOTASSIUM (UNII: 63FN7G03XY) (CLORAZEPIC ACID - UNII:D51WO0G0L4)

Available from:

Mylan Pharmaceuticals Inc.

INN (International Name):

CLORAZEPATE DIPOTASSIUM

Composition:

CLORAZEPATE DIPOTASSIUM 3.75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. Clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. The effectiveness of clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. Long-term studies in epileptic patients, however, have shown continued therapeutic activity. The physician should reassess periodically the usefulness of the drug for the individual patient. Clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal. Clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma.

Product summary:

Clorazepate Dipotassium Tablets, USP are available containing 3.75 mg, 7.5 mg or 15 mg of clorazepate dipotassium, USP. The 3.75 mg tablets are blue, round, scored tablets debossed with M above the score and 30 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0030-01 bottles of 100 tablets NDC 0378-0030-05 bottles of 500 tablets The 7.5 mg tablets are peach, round, scored tablets debossed with M above the score and 40 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0040-01 bottles of 100 tablets NDC 0378-0040-05 bottles of 500 tablets The 15 mg tablets are white, round, scored tablets debossed with M above the score and 70 below the score on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-0070-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Mylan Pharmaceuticals Inc.
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Medication Guide Clorazepate Dipotassium Tablets, USP CIV
(klor azʹ e pate dyeʺ poe tasʹ ee um)
What is the most important information I should know about clorazepate
dipotassium tablets?
•
Do not stop taking clorazepate dipotassium tablets without first
talking to your healthcare provider.
Stopping clorazepate dipotassium tablets suddenly can cause serious
side effects.
•
Clorazepate dipotassium is a benzodiazepine medicine. Taking
benzodiazepines with opioid
medicines, alcohol, or other central nervous system depressants
(including street drugs) can cause
severe drowsiness, breathing problems (respiratory depression), coma
and death.
•
Clorazepate dipotassium tablets can make you sleepy or dizzy and can
slow your thinking and
motor skills.
o
Do not drive, operate heavy machinery, or do other dangerous
activities until you know how
clorazepate dipotassium tablets affect you.
o
Do not drink alcohol or take other drugs that may make you sleepy or
dizzy while taking
clorazepate dipotassium tablets without first talking to your
healthcare provider. When taken
with alcohol or drugs that cause sleepiness or dizziness, clorazepate
dipotassium tablets may
make your sleepiness or dizziness much worse.
•
Clorazepate dipotassium tablets can cause abuse and dependence.
o
Do not stop taking clorazepate dipotassium tablets all of a sudden.
Stopping clorazepate
dipotassium tablets suddenly can cause seizures that do not stop
(status epilepticus), hearing
or seeing things that are not there (hallucinations), shaking,
nervousness, and stomach and
muscle cramps.
o
Talk to your healthcare provider about slowly stopping clorazepate
dipotassium tablets to
avoid withdrawal symptoms.
o
Physical dependence is not the same as drug addiction. Your healthcare
provider can tell you
more about the differences between physical dependence and drug
addiction.
•
Clorazepate dipotassium tablets are a federally controlled substance
(C-IV) because it can be
abused or lead to dependence. Keep clora

Summary of Product characteristics

CLORAZEPATE DIPOTASSIUM- CLORAZEPATE DIPOTASSIUM TABLET
MYLAN PHARMACEUTICALS INC.
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WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS
Concomitant use of benzodiazepines and opioids may result in profound
sedation, respiratory
depression, coma, and death (see WARNINGS, DRUG INTERACTIONS).
•
•
•
DESCRIPTION
Chemically, clorazepate dipotassium is a benzodiazepine. The molecular
formula is C
H ClK N O ;
the molecular weight is 408.92; 1_H_-1,4-Benzodiazepine-3-carboxylic
acid, 7-chloro-2,3-dihydro-2-
oxo-5-phenyl-, potassium salt compound with potassium hydroxide (1:1)
and the structural formula may
be represented as follows:
The compound occurs as a fine, light yellow, practically odorless
powder. It is insoluble in the
common organic solvents, but very soluble in water. Aqueous solutions
are unstable, clear, light
yellow, and alkaline.
Clorazepate dipotassium tablets, USP contain 3.75 mg, 7.5 mg or 15 mg
of clorazepate dipotassium, USP
for oral administration.
Inactive ingredients for clorazepate dipotassium tablets:
croscarmellose sodium, magnesium oxide,
magnesium stearate, microcrystalline cellulose, potassium carbonate,
sodium chloride and sodium
lauryl sulfate. The 3.75 mg tablets also contain FD&C Blue No. 2
Aluminum Lake and the 7.5 mg tablets
also contain FD&C Yellow No. 6 Aluminum Lake.
CLINICAL PHARMACOLOGY
Pharmacologically, clorazepate dipotassium has the characteristics of
the benzodiazepines. It has
depressant effects on the central nervous system. The primary
metabolite, nordiazepam, quickly appears
Reserve concomitant prescribing of these drugs for use in patients for
whom alternative
treatment options are inadequate.
Limit dosages and durations to the minimum required.
Follow patients for signs and symptoms of respiratory depression and
sedation.
16
11
2
2
4
in the blood stream. The serum half-life is about 2 days. The drug is
metabolized in the liver and
excreted primarily in the urine.
Studies in healthy men have shown that clorazepate dipotassium has
depressant effects on the cent